[Safety and use of gadobutrol in patients with brain tumors (phase III trial)].
OBJECTIVE
The purpose of the study was to investigate the use and safety of Gadobutrol, a new low-osmolar, non-ionic contrast agent for MRI using a total dose of 0.3 mmol/kg b.w. on the basis of a clinical phase 3 study.


METHODS
30 patients with primary brain tumours (n = 15) or cerebral metastases (n = 15) were examined via MRI before and after application of a total of 0.3 mmol/kg b.w. given in two fractions (0.1 and 0.2 mmol/kg b.w.). T2-weighted images were performed before, T1-weighted images before, between and after application of contrast material.


RESULTS
In this study one-molar Gadobutrol showed a good tolerance. In half of the cases the contrast between lesion and brain was improved comparing single and triple dose, but this means only a slightly improvement of information for the primary brain tumours compared with single dose. The detected metastatic lesions increased in 40% of the patients after the single dose and in 53% of the patients after cumulative triple dose. There was a consecutive change in therapy in 20% of the patients.


CONCLUSIONS
For the differentiation of primary brain tumours the single dose was sufficient, in metastatic lesions triple dose was essential for the detection or exclusion of multifocality.
Lemke
A J
AJ
Strahlenklinik und Poliklinik, Humboldt-Universität zu Berlin.
Sander
B
B
Balzer
T
T
Geens
V
V
Hosten
N
N
Felix
R
R
D000236:Adenoma / Q000175:diagnosis; D000328:Adult; D000368:Aged; D001254:Astrocytoma / Q000175:diagnosis; D001932:Brain Neoplasms / Q000175:diagnosis* / Q000556:secondary; D003287:Contrast Media / Q000008:administration & dosage; D003397:Craniopharyngioma / Q000175:diagnosis; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage; D018325:Hemangioblastoma / Q000175:diagnosis; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008579:Meningioma / Q000175:diagnosis; D008875:Middle Aged; D009837:Oligodendroglioma / Q000175:diagnosis; D009942:Organometallic Compounds / Q000008:administration & dosage; D010911:Pituitary Neoplasms / Q000175:diagnosis; D012449:Safety
D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D005682:Gadolinium
Sicherheit und Nutzen von Gadobutrol bei Patienten mit zerebralen Tumoren (Phase-III-Studie).